Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-01 @ 8:26 AM
Study NCT ID:
NCT06458569
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NK-ORB Expression of Mu Receptor on Lymphocytes in Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral blood samples from patients in EDTA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-04-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2024-06-10', 'studyFirstSubmitQcDate': '2024-06-10', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of percentage of Mu-positive NK cells as predictive markers of pain in suffering patients', 'timeFrame': '3 weeks', 'description': 'Peripheral blood of pain suffering patients who have entered a neurorehabilitation program will be investigated to confirm the modulation of the percentage of Mu-positive NK cells and to evaluate if they could be eligible as predictive markers of chronic pain by correlating it to the level of pain calculated with Numeric Pain Rating Scale.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Pain, NK cells, Lymphocytes, Mu Opioid Receptor'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'Chronic pain is a serious disorder that causes physical suffering and emotional distress.\n\nNK cells are cytotoxic granular cells playing a crucial role in innate immunity.\n\nRecent studies described modulation of the percentage of B lymphocytes and NK cells expressing the μ opioid receptor as a potential marker for measuring pain. Neuropathic pain sufferers have decreased NK cell function, highlighting the need of further investigating the effect of opioid receptor expression on lympoid cells defining their potential relevance as a pain monitor marker. Opioid receptors expressed on NK, B and T cells are a possible candidate for objective monitoring of pain in patients.', 'detailedDescription': 'Pain is a serious global problem Based on the preliminary data, peripheral blood of pain suffering patients who have entered a neurorehabilitation program will be investigated to confirm the modulation of the percentage of Mu-positive NK cells and to evaluate if they could be eligible as predictive markers of chronic pain.\n\nAll patients in the experimental group will undergo three blood sample collections at specific time points to evaluate the percentage of Mu-positive NK cells, and its modulation according to rehabilitation programs: the day of the enrollment (T0), at half part of the neuro rehabilitation programs (T1) and at the end of neuro-rehabilitation programs (T2). Particularly, the two study groups involved will be in a experimental group (50 consecutive patients who have an NRS \\>5); a control group (50 patients who have an NRS \\<5).\n\nPeripheral blood will be incubated with different fluorochrome-conjugated antibodies, specific for natural killer cells, in combination with anti-Mu Opioid Receptor (MOR) and the data will be analyze usin flow cytometer and FlowJo. The level of statistical significance will be fixed at p \\< 0.05. Analyses will be carried out using GraphPad Prism software (v8.00; GraphPad Software). The results are expressed as mean ± SEM The expected results from this study could support the hypothesis that modulation of the µ opioid receptor on NK cells is a valid method for pain measurement, helping to establish an innovative approach in a rehabilitation program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Experimental group, patients who have an NRS \\>5;\n* Control group, patients who have an NRS \\<5.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nIRCCS San Raffaele Roma patients who entered the neuro-rehabilitation program, aged 18 years older, able to sign a written informed consent.\n\nExclusion Criteria:\n\n* Patients with oncological or psychiatric diseases.\n* Pregnant patients\n* Patients with a severe psychiatric disorder (excluding mild depression) or mental/cognitive impairment'}, 'identificationModule': {'nctId': 'NCT06458569', 'acronym': 'NK-ORB', 'briefTitle': 'NK-ORB Expression of Mu Receptor on Lymphocytes in Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele Roma'}, 'officialTitle': 'Employment of Natural Killer Opioid Receptor as a Biomarker to Ameliorate the Efficacy of the Rehabilitation Program in a Patient-oriented Strategy', 'orgStudyIdInfo': {'id': 'RP 22/30'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy subjects', 'description': 'subjects with NRS\\<5'}, {'label': 'patients with cronical pain', 'description': 'patients with NRS\\>5', 'interventionNames': ['Other: Rehabilitation']}], 'interventions': [{'name': 'Rehabilitation', 'type': 'OTHER', 'description': '3-weeks rehabilitation in hospital', 'armGroupLabels': ['patients with cronical pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00163', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lucia Gatta, PhD', 'role': 'CONTACT', 'email': 'lucia.gatta@sanraffaele.it', 'phone': '+390652253440'}], 'facility': 'IRCCS San Raffaele', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Lucia Gatta, PhD', 'role': 'CONTACT', 'email': 'lucia.gatta@sanraffaele.it', 'phone': '+390652253440'}, {'name': 'Lucia Carmela Passacatini, Dr', 'role': 'CONTACT', 'email': 'carmela.passacatini@sanraffaele.it', 'phone': '+390652253778'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele Roma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}